Z-2107-2020Class II

Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913...

Name: Z-2107-2020 Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913...
Creator: Quest Medical, Inc.
Published: 2019-12-17
License: https://open.fda.gov/license/

Quest Medical, Inc / initiated 2019-12-17 / Terminated / root cause: labeling and UDI

FDA source

Quest Medical, Inc. began a recall of Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console... on 2019-12-17. FDA classified it as Class II and gives the reason as "Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2107-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-17
Posted: 2020-05-22
Terminated: 2024-04-17
Recalling firm: Quest Medical, Inc
Product: Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Customers who received product/affected lot were to be contacted via letter, Urgent-Product Recall Notice, dated 12/6/2019 sent to customers via XXX. Customers were to review their inventory to see if they had products from the affected lot. If they did have these products they were to place the product in quarantine and contact Quest Medical, Inc. using a form included with the recall notification. It instructed customers to complete and return the enclosed response form to Tosan Onosode Regulatory Affairs Supervisor,Quest Medical, Inc.,One Allentown Parkway Allen, TX 75002-4211 USA, Email: [email protected] Fax: +1 469-795-2338, Phone: +1 800-627-0226 ext. 338 so that they can arrange to correct the labeling defect on these units. It further stated that If customers had any questions or concerns regarding this action, they should contact Tosan Onosode, Regulatory Affairs Supervisor, Recall Coordinator at 1-800-627-0226, ext. 338.
Quantity in commerce: 5 units
Distribution: US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None
Product codes and lots: Lot Number: 059135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2107-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-22

Product code DTR

K173716Class IIMPS2 Myocardial Protection System ConsoleQuest Medical, Inc. / cleared 2018-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)